DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Claims 1, 3-15 and 23-34 are pending as of the response filed on 01/28/2026. Claims 2 and 16-22 are cancelled. Claims 1, 3-15 and 23-34 are examined herein.
The claim objections of previous record is withdrawn in consideration of the claim amendments.
The 35 U.S.C. 112(b) rejection of previous record is withdrawn in consideration of the claim amendments.
The 35 U.S.C. 112(d) rejection of previous record is withdrawn in consideration of the claim amendments. However, the amendment to overcome the 35 U.S.C. 112(d) rejection introduces new matter as discussed below. The 35 U.S.C. 112(a) rejection (new matter) was necessitated by the claim amendments.
The nonstatutory double patenting rejection of previous record has not been overcome and is maintained. Applicants arguments regarding the double patenting rejection has been fully considered and are addressed below.
Information Disclosure Statement
The information disclosure statement submitted on 01/28/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-4, 6-7, 10-11, 13 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim recites “E is selected from the group consisting of: N, C-H, and C-Rc, wherein Rc is selected from the group consisting of halogen, hydroxyl, alkoxy, C1-3 alkyl hydroxyl, C1-3 alkyl amino, C1-3 haloalkyl, C2-6 alkyl alkoxyl, C2-5 alkyl nitrile, and CN ”.
The recitation of “alkoxy” as an option for Rc is not supported by the original disclosure. Applicants assert on page 81 of their remarks dated 01/28/2026 that “Claims 1, 4, 5, 7, 8, 11, 14, 15, and 23-28 are amended. Support for the amendments to the claims may be found throughout the application and claims as filed, for example, at page 15, last paragraph; page 18, lines 18-24; and page 22, lines 19-22. Accordingly, no new matter is added.”. While it is true that the variable “Rd” has support for both “alkoxy” and “C2-5 alkyl nitrile” on page 22, lines 19-22 of the instant specification, instant claim 1 recites the variable “Rc” and not “Rd”. The variable “Rc” does not have support for the “alkoxy” group anywhere in the specification.
According to MPEP 2163.06, the introduction of new matter into claims is not allowed. Claims 3-4, 6-7, 10-11, 13 and 15 depend from the rejected base claim and do not remedy the introduction of new matter. Claims 3-4, 6-7, 10-11, 13 and 15 are similarly rejected.
This is a new matter rejection.
Double Patenting – Maintained and updated
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-14 and 23-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-14 and 23-34 of co-pending Application No 19/350,984.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compounds of Formula I, having almost identical variables.
The instant claims are drawn to
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568
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454
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The claims of the co-pending ‘984 application are drawn to
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423
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The compounds of Formula I of claims 1, 3-14 and 23-34 of the reference ‘984 application anticipates the compounds of Formula I of instant claims 1, 3-14 and 23-34.
The instant claims 1, 3-15 and 23-34 and claims 1, 3-14 and 23-34 of co-pending Application No 19/350,984 are therefore not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants argue on page 82 of the response dated 01/28/2026 that “Co-pending Application No. 19/350,984 is not subject to the prohibition against nonstatutory double patenting because it is entitled to the safe harbor protection for divisional applications set forth in 35 USC § 121. Divisional Application No. 19/350,984 was filed on October 6, 2025, as a result of the restriction requirement issued in this application on August 15, 2025. Divisional Application No. 19/350,984 was filed prior to issuance of the pending Office Action withdrawing such restriction requirement and prior to issuance of this application as a patent. Furthermore, and by virtue of the Amendment and Response to Notice to File Missing Parts of Nonprovisional Application filed on December 22, 2025, pending claims 1-34 in divisional Application No. 19/350,984 are directed to methods of using the Group I compound of the instant application, the subject matter of Group II of the restriction requirement set forth in the instant application. Thus, the claims in co-pending divisional Application No. 19/350,984 are consonant in scope with the claims subject to restriction in the instant, parent application. For at least these reasons, the protections of 35 USC § 121 apply, and divisional Application No. 19/350,984 cannot properly be used as a reference against the instant, parent application”.
Applicant's arguments have been fully considered but they are not persuasive.
As indicated in the previous Office action, the restriction requirement set forth in the Office action dated 08/15/2025 was withdrawn in the subsequent Office action dated 10/30/2025.
According to MPEP 804.01 subsections (C) and (E), the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply when:
(C) The restriction requirement was withdrawn because the requirement was written in a manner which made it clear to applicant that the requirement was made subject to the nonallowance of generic or other linking claims and such generic or linking claims are subsequently allowed.
(E) The requirement for restriction was withdrawn, in its entirety or in pertinent part, by the examiner before the patent issues. With the withdrawal of the restriction requirement, the non-elected claims that are no longer withdrawn from consideration become subject to examination. "The restriction requirement disappears; it is as though it had not been made. With the disappearance of the restriction requirement, the need for a divisional application and the need for the [double patenting] prohibition also disappear." In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 132 (CCPA 1971).
Although co-pending divisional Application No. 19/350,984 was filed on October 6, 2025, the claims in the reference co-pending application were not consonant in scope with the restriction requirement made by the examiner in the Office action dated August 15, 2025, as of the date of filing of the co-pending reference application. The restriction requirement was withdrawn by the examiner as of the Office action dated October 30, 2025. The claims of the co-pending divisional Application No. 19/350,984 were amended on December 22, 2025 to be consonant in scope after the restriction requirement was withdrawn (i.e., non-existent). Therefore, the divisional application, Application No. 19/350,984, does not get the safe harbor protection for divisional applications set forth in 35 USC § 121, since the instant application did not have a restriction requirement on file as of December 22, 2025.
Therefore, the nonstatutory double patenting rejection of record is maintained and updated to reflect the amendments to the instant and co-pending applications.
Allowable Subject Matter
Except for the 35 U.S.C. 112(a) rejection and non-statutory double patenting rejection above, all claims would be allowable.
Conclusion
Claims 1, 3-15 and 23-34 are rejected.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached on 9:00-5:30pm EDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PADMAJA S RAO/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627